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AsthmaPhase 4CONNECT1NCT03890666

A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma

A Phase 4 study testing Albuterol eMDPI DS and albuterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13… Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Asthma
What is being tested?
Albuterol eMDPI DS and albuterol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
29 sitesUnited States
Study dates
26 Oct 2020to 4 Oct 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The participant has a documented diagnosis of asthma
  • The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
  • The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
  • The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
  • Additional criteria apply, please contact the investigator for more information

Who cannot join

  • The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
  • The participant was hospitalized for severe asthma in the last 30 days.
  • The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
  • The participant is a current smoker or has a greater than 10 pack-year history of smoking.
  • The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
  • The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
  • Additional criteria apply, please contact the investigator for more information

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites
  • Teva Investigational Site 14304

    Albany, Georgia, 31707

  • Teva Investigational Site 14233

    Ann Arbor, Michigan, 48109

  • Teva Investigational Site 14197

    Aventura, Florida, 33180

  • Teva Investigational Site 14207

    Bellevue, Nebraska, 68123-4303

  • Teva Investigational Site 14232

    Birmingham, Alabama, 35209

  • Teva Investigational Site 14234

    Chapel Hill, North Carolina, 27599

  • Teva Investigational Site 14300

    Charleston, South Carolina, 29407

  • Teva Investigational Site 14187

    Cincinnati, Ohio, 45231

  • Teva Investigational Site 14236

    Colorado Springs, Colorado, 80907

  • Teva Investigational Site 14198

    Denver, Colorado, 80206

  • Teva Investigational Site 14217

    Evanston, Illinois, 60201

  • Teva Investigational Site 14190

    Greenfield, Wisconsin, 53228

  • Teva Investigational Site 14196

    Greenville, South Carolina, 29607

  • Teva Investigational Site 14302

    Los Angeles, California, 90025

  • Teva Investigational Site 14305

    Louisville, Kentucky, 40215

  • Teva Investigational Site 14306

    Miami, Florida, 33186

  • Teva Investigational Site 14220

    New Haven, Connecticut, 06510

  • Teva Investigational Site 14221

    New York, New York, 10461

  • Teva Investigational Site 14191

    Owensboro, Kentucky, 42301

  • Teva Investigational Site 14210

    Philadelphia, Pennsylvania, 19140

  • Teva Investigational Site 14208

    Pittsburgh, Pennsylvania, 15241

  • Teva Investigational Site 14200

    Providence, Rhode Island, 02906

  • Teva Investigational Site 14188

    San Antonio, Texas, 78207

  • Teva Investigational Site 14192

    San Antonio, Texas, 78229

  • Teva Investigational Site 14189

    San Antonio, Texas, 78251

  • Teva Investigational Site 14215

    Sarasota, Florida, 34239

  • Teva Investigational Site 14195

    Savannah, Georgia, 31406

  • Teva Investigational Site 14218

    Springfield, Illinois, 62704

  • Teva Investigational Site 14301

    Stockton, California, 95207-6204

Other trials in United States

About this study

Official title: CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma

This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.

The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).

Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.

Conditions
Asthma
Being tested
Albuterol eMDPI DS, albuterol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albuterol eMDPI DSDrug

    Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:

    • Device 1: Albuterol eMDPI
    • Device 2: Albuterol eMDPI Patient-facing smart device application (App)
    • Device 3: DHP Cloud solution)
    • Device 4: Provider-facing dashboard (dashboard)
  • albuterolDrug

    Standard of care albuterol-administering rescue inhaler

Study groups in NCT03890666
Study groupRoleWhat they receive
Digital System (DS)ExperimentalParticipants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product [IMP]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
Receives: Drug: Albuterol eMDPI DS
Concurrent Control (CC)Active comparatorParticipants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications.
Receives: Drug: albuterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period

    Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.

    Measured: Baseline to Week 12

Secondary outcomes (16)
  1. Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence

    Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.

    Measured: Baseline up to Week 12

  2. Number of Decreased Doses of Inhaled Medication

    Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.

    Measured: Baseline up to Week 12

  3. Number of Increased Doses of Inhaled Medication

    Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.

    Measured: Baseline up to Week 12

  4. Number of Changes to Different Inhaled Medication

    Number of participants who received different inhaled medication during the 12-week treatment period are reported.

    Measured: Baseline up to Week 12

  5. Number of Additional Inhaled Medication

    Number of participants who received additional inhaled medication during the 12-week treatment period are reported.

    Measured: Baseline up to Week 12

  6. Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy

    Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.

    Measured: Baseline up to Week 12

  7. Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control

    Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.

    Measured: Baseline up to Week 12

  8. Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group

    Measured: Baseline, Week 12

  9. Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group

    Measured: Baseline, Week 12

  10. System Usability Scale (SUS) Overall Score

    The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.

    Measured: Week 12

  11. Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12

    The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).

    Measured: Baseline, Week 12

  12. Change From Baseline in BMQ Necessity Subscale Score at Week 12

    The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).

    Measured: Baseline, Week 12

  13. Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12

    The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.

    Measured: Baseline, Week 12

  14. Change From Baseline in BIPQ Cognitive Subscale Score at Week 12

    BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 [no affect] - 10 [severe affect]), timeline (Item 2: How long do you think your illness will continue? Response range 0 [a very short time] - 10 [forever]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 [no control] - 10 [extreme amount of control]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 [not at all] - 10 [extremely helpful]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 [no symptoms] - 10 [severe symptoms]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.

    Measured: Baseline, Week 12

  15. Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12

    BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 [not at all concerned] - 10 [extremely concerned]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 [not at all affected emotionally] - 10 [extremely affected emotionally]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.

    Measured: Baseline, Week 12

  16. Number of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Number of participants with any AEs, treatment-related AEs, and device-related AEs has been reported.

    Measured: Baseline up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start26 Oct 2020
  3. Primary completion4 Oct 2021
  4. Study completion4 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890666
Sponsor's protocol ID
ABS-AS-40138
Acronym
CONNECT1
Status last verified
Mar 2026
First submitted
18 Mar 2019
Last updated
19 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albuterol eMDPI DS and albuterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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